FDA applicant

Harmac Medical Specialties, Inc.

Buffalo, NY1 decision1988–19880 recalls

FDA records 1 decision for Harmac Medical Specialties, Inc. (Buffalo, NY) in 1988: 1 510(k) clearance. All are in product code FPA (Set, Administration, Intravascular). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Harmac Medical Specialties, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Harmac Medical Specialties, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Harmac Medical Specialties, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Harmac”

FDA records each applicant name separately; these may or may not be the same firm.

Harmac Medical Products, Inc. 8

Harmac Medical Specialties, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Harmac”